Bringing a medical device to market can often involve complex technology and specific expertise. Often, two companies combine efforts, and when the collaboration involves joint technology development and regulatory approvals, the relationship may extend for a long period of time. These types of agreements can get complex because the IP and FDA rights have not yet been created and there are distinct IP issues that must be considered in parallel with the FDA regulatory process and obligations. This webinar will cover the key IP and FDA terms in medical device development and licensing agreements and will provide practical advice on typical issues and pitfalls that may arise. Regulatory, industry, and FDA attorneys will gain insight into typical IP and commercial issues and IP attorneys will gain a better understanding of FDA considerations.
Suzan Onel, Partner, Kleinfeld, Kaplan & Becker LLP
Tyler Maddry, Partner, Hunton & Williams LLP
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Suzan Onel is a partner at Kleinfeld Kaplan & Becker. Ms. Onel practices FDA law with a primary focus on regulatory issues involving medical devices, foods, dietary supplements, over-the-counter drugs, cosmetics and consumer products. She regularly advises international and domestic manufacturers, distributors, and researchers on market entry strategies, labeling and promotional activities, regulatory compliance, recalls and field corrections, and enforcement defense. Ms. Onel assists clients with the preparation of FDA submissions, including 510(k) premarket notifications, premarket approval applications (PMAs), food additive petitions, GRAS self-affirmations and notifications, food contact notifications, new dietary ingredient notifications, and adverse event reports. Ms. Onel’s experience includes representing clients before the U.S. Food and Drug Administration, the Federal Trade Commission, the U.S. Department of Agriculture, the Bureau of Alcohol, Tobacco, and Firearms, the National Advertising Division of the Better Business Bureaus, and similar international and state bodies. Ms. Onel’s practice also includes FDA due diligence investigations and advising companies and private equity/venture capital investors on transactional matters involving life science company acquisition, divestment and capital growth as well as supplier contracts and clinical research agreements. Ms. Onel earned her BA from the University of Pennsylvania, and her JD from the University of Virginia School of Law.
Tyler Maddry is a Partner at Hunton & Williams LLP. Mr. Maddry represents clients in licensing and enforcement of intellectual property rights, including drafting and negotiating patent and technology license agreements, joint development agreements, master services agreements, software license agreements, software as a service (SaaS) agreements, supply agreements, and trademark license agreements. He also has extensive experience in negotiating IP terms in M&A transactions, conducting IP due diligence investigations, litigation of intellectual property rights, and resolution of IP and technology disputes. His practice covers a range of industries, including information technology, healthcare, financial services, and telecommunications. Mr. Maddry is a member of the Licensing Executives Society and is admitted to practice before the U.S. Court of Appeals for the Federal Circuit and the U.S. District Courts for the District of Columbia, Eastern District of Virginia, Eastern District of Texas, and Northern District of New York. He is also registered with the U.S. Patent and Trademark Office. He earned his BA, cum laude, from Harvard University, and his JD, cum laude, from George Washington University Law School.